SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): April 26, 2019
Innovate Biopharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
incorporation or organization)
8480 Honeycutt Road, Suite 120, Raleigh, NC 27615
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, include area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Results of Operations and Financial Condition.
As of March 31, 2019, Innovate Biopharmaceuticals, Inc. (the "Company") had estimated unaudited cash and cash equivalents of $11.5 million. This is a preliminary unaudited estimate of the cash and cash equivalents of the Company as of March 31, 2019. This preliminary unaudited estimate has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, the Company's management. The Company's independent registered public accounting firm has not audited or reviewed, and does not express an opinion with respect to, this preliminary unaudited estimate. This preliminary unaudited estimate is not a comprehensive statement of the Company's financial position as of March 31, 2019, and remains subject to, among other things, the completion of the Company's financial closing procedures, final adjustments, and the quarterly review by the Company's independent registered public accounting firm, which may materially impact this preliminary unaudited estimate.
On April 26, 2019, the Company issued a press release announcing a webcast to present certain financial information for the fiscal quarter ended March 31, 2019 and corporate updates. A copy of the press release is attached as Exhibit 99.1 and is incorporated into this Item 2.02 by reference.
The information in this Current Report on Form 8-K furnished pursuant to Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, and they shall not be deemed not incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Regulation FD Disclosure.
The information presented in Item 2.02 above is incorporated herein by reference.
Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Innovate Biopharmaceuticals, Inc.
Date: April 26, 2019
/s/ Jay P. Madan
Jay P. Madan
President and Chief Business Officer
Innovate Biopharmaceuticals First Quarter 2019 Financial Results and Operational Progress Updates - Webcast Details
RALEIGH, N.C., April 26, 2019 - Innovate Biopharmaceuticals, Inc. (“Innovate”) (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel autoimmune and inflammation therapeutics, announced that company executives intend to host a webcast on Monday, April 29, 2019, at 8:00 AM ET, to provide clinical and operational progress updates, including details regarding the company’s Phase 3 celiac disease clinical trial.
Event: Webcast to Provide First Quarter 2019 Financial Results & Operational Progress Updates
Date: Monday, April 29, 2019
Time: 8:00am ET
Dial In: 877-705-2969
Please visit the Investor section of Innovate’s website for further details on how to participate. A live and archived audio webcast of the conference call will be available on the Events and Presentations page of the Innovate corporate website.
About Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT):
Innovate is a clinical stage biotechnology company
focused on developing novel therapeutics for autoimmune and inflammatory diseases. Innovate’s lead drug candidate, larazotide acetate, has a mechanism of action that renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in nonalcoholic steatohepatitis (NASH). In several diseases, including celiac disease, NASH, Crohn’s disease, ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes mellitus (T1DM), chronic kidney disease (CKD), the intestinal barrier is dysfunctional with increased permeability.
Forward Looking Statements
This press release includes forward-looking statements including, but not limited to, statements related to the development of drug candidates, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to our ability to obtain additional capital on favorable terms to us, or at all, including, without limitation, to fund our current and future preclinical studies and clinical trials and the success, timing and cost of our drug development program and our ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, as well as the risks that prior clinical and preclinical results may not be replicated. These risks and uncertainties include, but may not be limited to, those described in our Annual Report on Form 10-K filed with the SEC on March 18, 2019, and in any subsequent filings with the SEC. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.
Innovate Biopharmaceuticals, Inc.
Jennifer K. Zimmons, Ph.D.